Foot Pedal Occlusion Indicator System, Apparatus, and Method

ABSTRACT

A system, method and apparatus for notifying a surgeon of an occlusion in an ocular surgical apparatus are disclosed herein. Through operation of a handpiece of the surgical apparatus, the handpiece may become blocked or occluded. An occlusion detector is configured to sense the occlusion in the handpiece, and an occlusion signal is generated. A control module is provided to send an occlusion warning signal to a foot pedal of the surgical apparatus, where a tactile notification is provided to a user of the apparatus that an occlusion has occurred.

BACKGROUND

Field of Invention

The present disclosure relates generally to medical methods, systems andapparatuses, and more particularly, to methods, systems and apparatusfor detecting and indicating one or more surgical aspects of a medicalprocedure.

Description of Related Art

Ophthalmic surgical apparatuses typically include operating controls forregulating settings or functions of the apparatus. Numerous types ofapparatuses include, as part of the apparatus, a hand-held medicalimplement or tool, such as a handpiece with a tip. Operation of the toolrequires control of various operating settings or functions based on thetype of tool used and the type of operation being performed. Suchapparatuses typically include a control module, power supply, anirrigation source, one or more aspiration pumps, as well as associatedelectronic hardware for operating a multifunction handheld surgical toolin order to emulsify eye tissue, irrigate the eye with a salinesolution, and aspirate the emulsified lens from the eye.

A number of medically recognized techniques are utilized for crystallinelens removal based on a variety of technologies, for example,phacoemulsification or vitrectomy. Phacoemulsification and vitrectomyprocedures may require fluid control, namely control over aspiration andirrigation to the ocular region, and employ a handpiece that istypically electrically driven and must be controlled. The handpiece orsimilar apparatus is especially constructed for breaking apart andremoving the natural, crystalline lens of a patient's eye, inpreparation for insertion of an artificial lens. A phacoemulsificationapparatus may involve a console that contains or holds the controlmodule, power supply, and irrigation source, with the console beingmovable so that these components can be arranged in a beneficial mannerduring a procedure, typically just outside of the surgical procedurearea. The handpiece is arranged to extend into the surgical procedurearea, specifically the ocular region.

It should be appreciated that controlling or changing the functions oroperations of the handpiece from the remote console or control module isgenerally unsatisfactory for the surgeon or operator of the handpieceduring a surgical operation. During operation, the surgeon's focusshould optimally be on the surgical area, not the remote console.Accordingly, in view of the handheld instrumentation necessary for aphacoemulsification procedure, foot controls are frequently provided inorder to control and facilitate use of the handpiece, such as a fluidhandpiece during surgery, and control of the handpiece may be providedto the surgeon via a foot pedal. Foot pedals vary in design, but moremodern foot pedals include a treadle that can be moved in a fore-and-aftdirection (a pitch motion) and in a left-and-right direction (a yawmotion). Hard switches may also be provided, where the switchestypically provide a toggle functionality and/or an on-off functionality.Control may be provided for various device components and operations forthe phacoemulsification, diathermy or vitrectomy machine through thefoot pedal, including control of fluid flow, entry into various modes,electrical parameters, speed parameters (e.g. cut speed), and so forth.Despite the output from such foot pedals in regulating or controllingthe apparatus, the pedal, and the entire system, must be user friendlyin order to provide a surgeon comfort and reliability in its use so asnot to initiate disruption of the surgeon's concentration whenperforming surgery.

Phacoemulsification includes making a corneal and/or scleral incisionand the insertion of a phacoemulsification handpiece that includes aneedle or tip that is ultrasonically driven to emulsify, or liquefy, thelens. A phacoemulsification system typically includes a handpiececoupled to an irrigation source and an aspiration pump. In variousembodiments, the handpiece includes a distal tip that emits ultrasonicenergy to emulsify a crystalline lens within the patient's eye. Thehandpiece includes an irrigation port proximal to the distal tip andcoupled to the irrigation source via an irrigation input line. Thehandpiece further includes an aspiration port at the distal tip that iscoupled to the aspiration pump via an aspiration output line.Concomitantly with the emulsification, fluid from the irrigation source(which may be a bottle or bag of saline solution that is elevated abovethe field of surgery) is irrigated into the eye via the irrigation lineand the irrigation port. This fluid is directed to the crystalline lensin the patient's eye in order to maintain the anterior chamber andcapsular bag and replenish the fluid aspirated away with the emulsifiedcrystalline lens material. The irrigation fluid in the patient's eye andthe crystalline lens material are aspirated or removed from the eye bythe aspiration pump and line via the aspiration port. Additionally, someprocedures may include irrigating the eye and aspirating the irrigationfluid without concomitant destruction, alteration or removal of thelens.

Phacoemulsification and vitrectomy procedures typically require precisefluid control, namely control over aspiration and irrigation to theocular region, and employ a handpiece that is typically controlledelectrically in order to, for example, precisely control the flow offluid through the handpiece and tip. Such control is necessary, forexample, to maintain a stable volume of liquid in the anterior chamberof the eye, which may be accomplished by irrigating fluid into the eyeat the same rate as fluid and/or lens material is aspirated from theeye. During such operations, however, it is possible for the flow offluid out of or into the handpiece to be occluded or blocked. Such anocclusion may occur, for example, from particles (e.g. particles fromthe crystalline lens) blocking a port, lumen or tube associated with theirrigation input line or the aspiration output line. Such blockage candisrupt the flow of fluid into or out of the eye, for example, bycreating an imbalance of fluid flow that can result in an increasednegative pressure in the eye. Conversely, such a blockage could resultin a volumetric fluid flow drop off near the aspiration port. For suchsurgical procedures, it is necessary for the surgeon or other medicalpersonnel to understand and account for specific aspects of the surgicalprocedure, such as whether a stable volume of fluid is in the eye orwhether an occlusion has occurred, in order to effectively perform theoperation.

In prior systems, the occurrence of an occlusion has been communicatedto a surgeon or user via either an audio tone or a visual indicator on adisplay associated with a control module of the surgical apparatus. Acomputer system associated with the control module may be electronicallyconnected to a sensor that monitors the flow of fluid into and out ofthe handpiece, or a sensor that otherwise detects changes in the rate offluid flow into the eye or the pressure of the fluid in the eye, inorder to determine if an occlusion has occurred. Such a system may beable to detect small changes in the fluid flow rate that would otherwisego unappreciated (or be mistaken) by a surgeon or other user of thehandpiece. A pre-determined amount of flow rate change may be programmedinto the system, such that if the flow rate change reaches or surpassesthe pre-determined amount, the system will know that an occlusion isoccurring or has occurred. Other forms of detecting the occurrence of anocclusion are known in the art.

Once an occlusion has been detected, the system will typically sound anaudio alarm or provide a visual indicator on the display screen toinform the surgeon of the occlusion. However, such systems have variousdisadvantages. For instance, use of an audio tone can be distracting orstartling to a surgeon or user of the handpiece, who are required toperform detailed and specific movements of the handpiece during asurgical operation. An audio tone may also be startling or intimatingfor the patient undergoing the surgical procedure. While a traditionalaudible tone may be enabled or disabled and the volume adjusted, thenature of how occlusions occur, and clear, sometimes results in therapid cycling of the audible tone (as multiple occlusions occur andclear in quick succession, for example). Such an audible tone may be sodistracting that a surgeon prefers to turn the tone off completely.

Alternatively, use of a visual indicator on a display may also beproblematic because such visual indicator is displayed on the console ofthe surgical apparatus. A surgeon is not typically looking at, or evenusing, a console display while performing surgery, instead keeping thefocus of their attention on the patient and the procedure beingperformed with the handpiece. In illustrative examples, a surgeon mayactually be viewing the patient's eye through a surgical microscope andhas no view of the console display. One alternative to this is toincrease the visual effect of the indicator (larger, brighter, etc.),however if a visual indicator is substantial enough, it can also havethe effect of distracting or startling the surgeon and/or patient, asdiscussed above.

Based on the foregoing, it would be advantageous to provide a means ofnotification of automatic detection of an occlusion to a surgeon withoutinterruption or distraction to the surgeon or patient during surgery.Such a design would afford a surgeon the ability to perform desiredphacoemulsification, diathermy, or vitrectomy functions with less needto worry about an abrupt audio tone, or a potentially unnoticed ordistracting visual indicator, when an occlusion is occurring or hasoccurred. Moreover, such a design would reduce the introduction of humanerror that can occur during the surgical procedure that occurs becausethe surgeon is startled by, or does not understand the reason for, theaudio or visual signal.

SUMMARY

According to one aspect of the present invention, an ocular surgicalapparatus comprises an intraocular lens removal device having ahandpiece and a foot pedal for a surgeon to operatively control thesurgical device, the handpiece configured to irrigate fluid into the eyeand aspirate fluid out of the eye so as to maintain a substantiallysteady or constant amount of fluid within the eye during surgery, thedevice further comprising a subsystem or electronic system of theapparatus that detects the occurrence of an occlusion or blockage offluid flowing into or out of the eye and thereafter causes a vibrationmechanism in the foot pedal to vibrate, or a forced feedback mechanismin the foot pedal to increase resistance against compression of the footpedal, in order to inform the surgeon operating the apparatus about theocclusion.

According to another aspect of the present invention, a method ofindicating that an occlusion has occurred in a handpiece of aphacoemulsification/diathermy/vitrectomy system comprises starting aflow of fluid through a tip of the handpiece, sensing whether anocclusion has occurred within the tip, and if an occlusion has occurred,sending an alert or notification signal to a vibration or forcedfeedback mechanism in a foot pedal of thephacoemulsification/diathermy/vitrectomy system to cause a vibration orforced feedback sensation to be felt by the surgeon's foot.

According to another aspect of the present invention, a vibrationmechanism may be located within a foot pedal of a surgical apparatussystem, the vibration mechanism configured to receive a command from acontrol module of the system when the system has detected that anocclusion has occurred in a handpiece being used in the surgicalprocedure, the vibration mechanism configured to vibrate a treadle, heelcup, or other engaging surface of the foot pedal upon receive of suchcommand, where such engaging surfaces are configured to typically be incontact with the surgeon's foot during the surgical procedure.

According to another aspect of the present invention, a forced feedbackmechanism may be located within a foot pedal of a surgical apparatussystem, the forced feedback system configured to receive an occlusionalert command from a control module of the system when the system hasdetected that an occlusion has occurred in a handpiece being used in thesurgical procedure, the forced feedback system typically configured toapply a resistance pressure to the treadle of the foot pedal when in useto bias the foot pedal to a unengaged/uncompressed position butpermitting downward pitching motion of the treadle when a user appliesdownward pressure to the treadle, wherein the forced feedback mechanismis further configured to increase the resistance pressure applied to thetreadle upon receipt of the occlusion alert command, thereby increasingthe amount of pressure a user must apply to the treadle to press down onthe treadle during the surgical operation.

Other systems, methods, features and advantages of the invention will beor will become apparent to one of skill in the art upon examination ofthe following figures and detailed description. It is intended that allsuch additional systems, methods, features and advantages be includedwithin this description, be within the scope of the invention, and beprotected by the accompanying claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The organization and manner of the structure and function of thedisclosure, together with the further objects and advantages thereof,may be understood by reference to the following description taken inconnection with the accompanying drawings, and in which:

FIG. 1 illustrates a diagram of an exemplaryphacoemulsification/diathermy/vitrectomy system in accordance with thepresent disclosures, the system including a handpiece for use during asurgical procedure and a foot pedal;

FIG. 2A is a perspective view an exemplary embodiment of a foot pedal inaccordance with the present disclosure, the foot pedal in a firstuncompressed state;

FIG. 2B is a view of the foot pedal of FIG. 2A in a second compressedstate;

FIG. 3A is a cross-sectional view taken along the line 3A-3A in FIG. 2A;

FIG. 3B is a bottom perspective view of a foot pedal in accordance withthe present disclosure with a base of the foot pedal removed;

FIG. 4A is a cross-sectional view of another exemplary embodiment of afoot pedal in accordance with the present disclosure;

FIG. 4B is a top perspective view of the foot pedal of FIG. 4A;

FIG. 5A is a cross-sectional view of another exemplary embodiment of afoot pedal in accordance with the present disclosure;

FIG. 5B is a perspective view of the foot pedal of FIG. 5A;

FIG. 6A is a cross-sectional view of another exemplary embodiment of afoot pedal in accordance with the present disclosure;

FIG. 6B is a cross-sectional view of another exemplary embodiment of afoot pedal in accordance with the present disclosure; and

FIGS. 7 and 8 illustrate block diagrams showing a flow chart anembodiment of the method of the utilizing the system of FIG. 1 inaccordance with the present disclosure to perform a surgical procedure.

DETAILED DESCRIPTION

The following description and the drawings illustrate specificembodiments sufficiently to enable those skilled in the art to practicethe described system and method. Other embodiments may incorporatestructural, logical, process and other changes. Examples merely typifypossible variations. Individual components and functions are generallyoptional unless explicitly required, and the sequence of operations mayvary. Portions and features of some embodiments may be included in orsubstituted for those of others.

A system and method for indicating an occlusion has occurred in a tip ofa handpiece of a surgical system, which can be applied to any system,medical or non-medical, are disclosed herein. In illustrativeembodiments, the system and method include means for automaticallydetecting the occlusion in the handpiece and automatically sending asignal to a tactile indicator within a foot pedal of the system to causea tactile notification of the occlusion to be felt by the surgeon usingthe foot pedal.

Embodiments of a subsystem and method will be discussed herein with aparticular emphasis on a medical or hospital environment where a surgeonor health care practitioner performs. For example, an illustrativeembodiment of the system is a phacoemulsification surgical system thatcomprises an integrated high-speed control module for a vitrectomyhandpiece that irrigates and aspirates fluid from the eye through a tipconnected to the handpiece. The system further comprises sensors todetect whether an occlusion has occurred, such as a sensor that detectswhether the flow of fluid into or out of the eye has been disrupted orblocked, and a processor that determines if an occlusion has occurred inthe tip of the handpiece from the data collected. The system furtherincludes a foot pedal that used by the surgeon for controlling thehandpiece during a surgical operation, the foot pedal further includinga tactile indicator that can provide a sensory stimulation to thesurgeon's foot when it receives the signal from the processor indicatingthat an occlusion has occurred.

FIG. 1 illustrates an exemplary phacoemulsification/diathermy/vitrectomysystem 100. As illustrated, the system 100 includes, for example, ahandpiece or wand 20, an irrigation source 30, an aspiration source 40,a foot pedal 50, and a control module 60. In this embodiment, fluid iscontrollably directed through the system 100 in order to irrigate apatient's eye, illustrated representatively at 10, during an ocularsurgical procedure. Various embodiments of the handpiece 20, irrigationsource 30, aspiration source 40, foot pedal 50, and control module 60are well known in the art and are embodied in this disclosure.

As illustrated in FIG. 1, the irrigation source 30 is configured tosupply a predetermined amount of fluid to the handpiece 20 for useduring surgical operation. Specifically, fluid may flow from theirrigation source 30 to the handpiece 20 via an irrigation line 32. Theirrigation source 30 may be any type of irrigation source 30 that cancreate and control a constant fluid flow. For instance, the irrigationsource 30 may create and control a constant fluid flow such that vacuumpressure may be determined in the fluid flow, as known in the art. Inillustrative embodiments, the irrigation source 30 may be configured tobe an elevated drip bag 34 that supplies a steady state of fluid to theirrigation line 32. In illustrative embodiments, a pressure supply (notshown) may be coupled to the irrigation source 30 in order to maintain aconstant pressure in the irrigation source 30 as fluid exits theirrigation source 30, as is known in the industry. Other embodiments ofa uniform irrigation source are well known in the art.

During the surgical procedure, fluid may be delivered to the eye via thehandpiece 20, and fluid may further be aspirated from the eye via thehandpiece 20 to flow through an aspiration line 42 to the aspirationsource 40. The aspiration source 40 may be any type of aspiration source40 that aspirates fluid and material from the eye. For instance, theaspiration source may create a fluid flow such that vacuum pressure maybe determined in the fluid flow. In illustrative embodiments, theaspiration source 40 may be configured to be a flow-based pump (such asa peristaltic pump) or a vacuum-based pump (such as a Venturi pump) thatare well known in the art. The aspiration source 40 may create a vacuumsystem to pump fluid and/or material out of the eye via the aspirationline 42.

The handpiece 20 includes a first end 22 and a second end 23 thatincludes a tip 24. The tip 24 includes an irrigation port 26 and anaspiration port 28. The irrigation port 26 is fluidly coupled to theirrigation line 32 to receive fluid flow from the irrigation source 30,and the aspiration port 28 is fluidly coupled to the aspiration line 42to receive fluid and/or material flow from the eye. The handpiece 20 andthe tip 24 may further emit ultrasonic energy into the patient's eye,for instance, to emulsify or break apart the crystalline lens within thepatient's eye. Such emulsification may be accomplished by any knownmethods in the industry, such as, for example, a vibrating unit (notshown) that is configured to ultrasonically vibrate and/or cut the lens,as is known in the art. Other forms of emulsification, such as a laser,are well known in the art. Concomitantly with the emulsification, fluidfrom the irrigation source 30 is irrigated into the eye via theirrigation line 32 and the irrigation port 26. During and after suchemulsification, the irrigation fluid and emulsified crystalline lensmaterial are aspirated from the eye by the aspiration source 40 via theaspiration port 28 and the aspiration line 42. Other medical techniquesfor removing crystalline lenses also typically include irrigating theeye and aspirating lens parts and other liquids. Additionally, otherprocedures may include irrigating the eye and aspirating the irrigatingfluid without concomitant destruction, alternation or removal of thelens.

Due to the nature of the tip 24 and the procedures that occur during asurgical operation, the irrigation port 26 and the aspiration port 28may be aligned close to each other adjacent a distal end of the tip 24.During aspiration from the eye, fluid and/or lens material is circulatedthrough the eye and the aspiration port 28 is configured to remove (forexample, by force of suction) the fluid and/or material from the eye.Depending on the size of the lens material and the sizes/types of theirrigation port 26 and the aspiration port 28, lens material may clog orblock flow of the irrigation port 26 or the aspiration port 28, known asan occlusion. An occlusion is caused by particles blocking a lumen ortube being used to aspirate or irrigate the eye (e.g. the irrigationport 26 or aspiration port 28). This blockage results in increasedvacuum (i.e. increasingly negative pressure) in the aspiration line 42.The longer the occlusion is in place, the greater the vacuum. Once theocclusion is cleared, a resulting rush of fluid from the anteriorchamber into the aspiration line 42 can outpace the flow of new fluidinto the eye from the irrigation source 30.

The system 100 may be configured to detect such an occlusion occurringat the handpiece during operation, which may be communicated to anoperator to permit correction of the occlusion, or permit the operatorto adjust the settings of the apparatus accordingly. For instance, thesystem 100 may include a subsystem (not shown) that detects such anocclusion, as explained, for example, in U.S. Published Application No.2009/0048607, filed Aug. 13, 2007 and incorporated by reference herein.Other methods for detecting the occurrence of an occlusion are known inthe art. The subsystem may communicate to the control module 60 that anocclusion has occurred, and the control module 60 may conduct furtheranalysis or provide a warning indicator to the surgeon that an occlusionhas occurred.

As illustrated in FIGS. 2A-6B, the present disclosure is directed to anapparatus and method of communicating the occurrence of an occlusion toa surgeon or operator of the handpiece through use of the foot pedal 50.Specifically, the foot pedal 50 is coupled to the control module 60 viaa communication path 62 and includes an occlusion alarm 80. In additionto permitting the operator to control the operation and function of thehandpiece 20 via engagement with the foot pedal 50, the communicationpath 62 also permits the control module 60 to send a signal to the footpedal 50 to control operation of the occlusion alarm 80. The controlmodule 60 may send a signal to cause the occlusion alarm to engage andalert the operator of an occlusion if an occlusion is detected by thecontrol module 60. The communication path 62 may comprise an electricalwire, as illustrated in FIG. 1, or may be a wireless connection betweenthe control module 60 and the foot pedal 50. Other forms ofcommunication paths 62 are known in the art and encompassed in thepresent disclosure.

In illustrative embodiments, the foot pedal 50 comprises a treadle 52, abody housing 54, and a base 56 on which the body housing 54 is mounted,as illustrated for example in FIG. 2A. The base 56 has a bottom surface58 arranged to lie flat on the ground surface. More specifically, thebottom surface 58 is either flat or a series of separate feet (notshown) may be provided to create a stable base surface on the ground.The base 56 may provide improved stability in various embodiments,including a gripping surface, such as rubber, rubberized, plastic or thelike traction strips or treads (not shown).

In illustrative embodiments, the treadle 52 comprises a top surface 43and a bottom surface 44. The top surface 43 may include traction strips,plastic or rubber surface to provide traction for a user's foot whenengaging with the treadle 52. The treadle 52 may be coupled to the bodyhousing 54 to permit rotation of the treadle 52 with respect to thehousing 54 about a pivot point 46, as illustrated, for example, in FIGS.3A and 4A. The treadle 52 may rotate from a first (uncompressed)position 102 to a second (compressed) position 104, and any positiontherebetween, as illustrated in FIGS. 2A and 2B. In various embodiments,the treadle 52 may be naturally biased to the first position 102 by anyknown biasing means 48. Such a biasing means may include, for example, aspring 49, but other means of biasing are well known in the art.

In illustrative embodiments, the body housing 54 is configured to extendupward from the base and substantially defines the outer periphery ofthe foot pedal 50. The body housing 54 comprises a left side wall 61, aright side wall 63, a back side wall 64, and a top surface 66, asillustrated in FIG. 2A. The top surface 66 is configured to include aninner radial edge 68 that defines an aperture 69 into the body housing54, the aperture 69 configured to receive the treadle 52 as illustrated.The body housing 54 and the base 56 are configured to define an opening70 within the foot pedal 50 to permit downward rotation of the treadle52 when the treadle 52 is compressed by a user's foot. In variousembodiments, the body housing 54 may further include a front side wall(not shown) connected to the left side wall 61 and the right side wall63 to further enclose the opening 70.

As illustrated in FIG. 4B, the top surface 66 of the body housing mayfurther include one or more switches 72 that may be depressed by auser's foot to engage various functions or operations of the system.Such switches are known in the art, as illustrated, for example, in U.S.Published Application No. 2014/036864, incorporated by reference herein.In other illustrative embodiments, the body housing 54 may also includean inner wall 74 that extends to the inner radial edge 68, the innerwall 74 including further switches 72 for controlling the function ofthe system, as illustrated in FIG. 5B. Other various configurations ofcontrollers on a foot pedal 50 may include, for example, switches on thetreadle. In illustrative embodiments, the switches 72 permit the surgeonto control various functions of the system through communication withthe control module 60. In various embodiments, the switches 72 cancommunicate with the control module 60 via the same communication path62 that the control module 60 uses to communicate with the occlusionalarm 80.

In illustrative embodiments, the occlusion alarm 80 may be a tactileindicator comprising a vibration mechanism 78. The vibration mechanism78 may include a motor 82 and an off-center weight 84, as illustrated inFIG. 3A. The motor 82 is configured to be electronically coupled to thecommunication path 62 to receive a signal from the control module 60when an occlusion has occurred. The motor 82 is configured to rotate theoff-center weight 84 upon receipt of the signal that an occlusion hasoccurred. In illustrative embodiments, the off-center weight may beconfigured to rotate about a rotation axis 90. In illustrativeembodiments, the off-center weight 84 includes a heavier-side portion 91that rotates about the rotation axis 90 to cause the weight 84 (andcomponents connected to the weight 84) to vibrate. Specifically, whenthe off-center weight 84 rotates, the imbalance of the heavier-sideportion 91 causes the off-center weight and components surrounding theoff-center weight to move slightly as the center of gravity shifts. Thevibration may occur for as long as the occlusion is detected by thesystem. Such vibration mechanisms 78 are known, for example, in theelectronics industry.

The vibration mechanism 78 may be coupled to various components of thefoot pedal 50 to cause the foot pedal 50 to vibrate. For instance, thevibration mechanism 78 may be coupled to the bottom surface 44 of thetreadle 52, as illustrated in FIG. 2A. In such an embodiment, thevibration mechanism 78 may be configured to rotate with the treadle 52about pivot point 46 when the treadle 52 is compressed into the opening70. The vibration mechanism 78 may be fixedly connected to the bottomsurface 44 of the treadle 52, for example via a bracket 38 surroundingthe motor 82. In other embodiments, the vibration mechanism 78 may becoupled to the base 56 of the foot pedal 50 and remain stationary whenthe treadle 52 is compressed. Other connection locations for thevibration mechanism 78 are also within the scope of this disclosure.

In another illustrative embodiment, the vibration mechanism 78 may beconfigured to cause a heel portion 36 of the top surface 66 of thehousing 54 to vibrate. As illustrated in FIGS. 4A and 4B, the heelportion 36 may be located adjacent where an operator's heel would beplaced when using the foot pedal 50. The vibration mechanism 78 may belocated adjacent the heel portion 36 and configured to vibrate the heelportion 36 when the vibration mechanism 78 is engaged. The vibrationmechanism 78 may be of the type as described previously with a motor 82and an off-center weight 84. Alternatively, the vibration mechanism 78may include a motor 82 and a rotating vane wheel 88 with one or moreprojections or fins 89. The rotating vane wheel 88 may be rotated by themotor 82 about a rotation axis 90 to cause the one or more fins 89 toengage with or hit against a bottom surface 37 of the heel portion 36upon rotation, causing vibrations to the heel portion 36. Other meansfor causing vibration that can provide tactile notification to anoperator are within the scope of this disclosure.

In another illustrative embodiment, the vibration mechanism 78 may beconfigured within a heel cup assembly 92 connected to the foot pedal 50.As illustrated in FIGS. 5A and 5B, heel portion 36 of the heel cupassembly 92 may include an upper portion comprising a heel loop 94, anda lower portion comprising a heel cup 96. The heel loop 94 may besubstantially rigid and may or may not be static during use of the footpedal 50. Further, the heel loop 94 may be adjustable, such as byallowing for an increase or decrease in the lateral distance from therearmost point of the heel loop 94 and front most portion of the footpedal 50. The heel cup 96 may provide at least one angular surface 95 tocontact at least a portion of the user's heel to cause the user's heelto be retained or positioned within the cup 96. The heel cup 96 includesa contact surface 98 onto which the heel of the user may rest. When thevibration mechanism 78 is located adjacent the contact surface 98, thecontact surface may provide vibration or tactile notification to theuser's heel within the heel cup assembly 92 than an occlusion hasoccurred.

In another illustrative embodiment, the occlusion alarm 80 may be atactile feedback indicator comprising a feedback mechanism 76, asillustrated in FIGS. 6A and 6B. The feedback mechanism 76 may include abase 86 coupled to the base 56 of the foot pedal 50. When the controlmodule 60 sends a signal to the base 86 that an occlusion has occurred,the feedback mechanism 76 is configured to create additional upwardforce or pressure upon the treadle 52. As a user or surgeon presses downon the treadle 52 during operation, the additional upward force orpressure will provide tactile indication that an occlusion has occurred.The additional or increased pressure may remain constant (or increase)until the occlusion has been removed or reduced.

In illustrative embodiments, the upward pressure of the feedbackmechanism 76 may be created by a biasing member 48 that is configured tobias against the bottom surface 44 of the treadle 52. The base 86 mayinclude a compression plate 87 or other similar device that can providecompressive force against the biasing member 48. The feedback mechanism76 may be positioned anywhere along the length of the base 56 of thefoot pedal 50 (as illustrated for example in FIGS. 6A and 6B) such thatit can engage with the bottom surface 44 of the treadle 52. Otherembodiments for a force feedback are envisioned, e.g. force applied toor adjustment to the tension of biasing means 48.

As illustrated in FIG. 7, the process of indicating an occlusion isconfigured to occur during the surgical procedure. In illustrativeembodiments, the surgical procedure is started at step 200, and a tip 24is attached to the handpiece 20 at step 202. Fluid begins to flowthrough the tip 24 at step 204 in order for the surgeon to irrigate andaspirate the eye of the patient. During this procedure, an occlusionsensor is configured to determine if an occlusion has occurred in thetip 24, as shown in step 206. If an occlusion has not occurred, thesystem will continue to perform as normal and no indicator or warningwill be conveyed to the operator, as shown in steps 208 and 210. Thesystem may be configured to continuously determine if an occlusion hasoccurred, for example as shown in the transition from step 210 to step206, at predetermined time intervals. In an another embodiment, thesystem may be configured to detect an occlusion upon an occurrence of anevent, e.g. detection of a decrease in flow rate and/or increase invacuum rate and/or increase in vacuum above a preprogrammed or setthreshold. If an occlusion has been detected, the system may indicatethat occlusion has occurred in step 212, and thereafter send a signal tothe foot pedal 50 to engage the occlusion alarm 80 in step 214. If theocclusion alarm 80 alerts the operator of an occlusion, the operator maythen adjust the procedure accordingly to avoid detrimental effects ofthe occlusion. The system may be configured to continuously determine ifan occlusion still exists, for example as shown in the transition fromstep 214 to step 206, at predetermined time intervals. If the systemdetects that no occlusion exists anymore, than the system will stopsending a signal to the foot pedal 50 to engage the occlusion alarm 80,as illustrated in step 210, the occlusion alarm 80 may stop indicatingan occlusion has occurred. As further illustrated in FIG. 8, if noocclusion is detected, the system may continue to continuously determineif an occlusion exists by, for example, reading occlusion sensor 206.

In illustrative embodiments, the control module 60 is configured tomonitor and control various components of the system 100, including thehandpiece 20 and whether the tip 24 of the handpiece 20 is occluded. Thecontrol module 60 may be in a variety of forms as known in the art. Inillustrative embodiments, the control module 60 may include amicroprocessor computer 110, a keyboard 112, and a display or screen114, as illustrated in FIG. 1. The microprocessor computer 110 may beoperably connected to and control various other components of thesystem, including the functionality and operation of the handpiece 20and the vibration mechanism 78 or feedback mechanism 76 of the footpedal 50. The keyboard 112 and display 114 permit a user to interactwith and control the system components as well. As may be appreciated bythose skilled in the arts, and virtual keyboard and/or touchscreen, forexample, may be used to provide the same functionality of keyboard 122and display 114. In illustrative embodiments, the control module 60 mayalso include a pulsed ultrasonic power source (not shown) that can becontrolled by the computer 110 in accordance with known methods oralgorithms in the art.

In an embodiment of the present invention, a method of detecting anocular occlusion may comprise the generation of at least one signal fromthe occlusion sensor 206 when, for example, the tip 24 of the handpiece20 is occluded. The signal generated may be of a length or strengthrelative to the occlusion encountered. By way of example, an occlusionmay be discrete but may be large enough to create a large drop inpressure in the handpiece 20 for which a relatively high frequencysignal may be read by the control module 60 for the actuation of analert indicative of such an occlusion. Similarly, a plurality ofocclusions may not result in a relatively large pressure drop but may,for example, propagate a pressure drop over a larger period of time forwhich a signal may be produced over substantially the same period oftime to allow for an alert commensurate with the length of time thepressure in the handpiece 20 deviates or varies from the desired orpredetermined pressure in the handpiece 20.

Those of skill in the art will recognize that any step of a methoddescribed in connection with an embodiment may be interchanged withanother step without departing from the scope of the invention. Those ofskill in the art would further appreciate that the various illustrativelogical blocks, modules, circuits, and algorithm steps described inconnection with the embodiments disclosed herein may be implemented aselectronic hardware, computer software, or combinations of both. Toclearly illustrate this interchangeability of hardware and software,various illustrative components, blocks, modules, circuits, and stepshave been described above generally in terms of their functionality.Whether such functionality is implemented as hardware or softwaredepends upon the particular application and design constraints imposedon the overall system. Skilled artisans may implement the describedfunctionality in varying ways for each particular application, but suchimplementation decisions should not be interpreted as causing adeparture from the scope of the present invention.

The various illustrative logical blocks, modules, and circuits describedin connection with the embodiments disclosed herein may be implementedor performed using a general purpose processor, a digital signalprocessor (DSP), an application specific integrated circuit (ASIC), afield programmable gate array (FPGA) or other programmable logic device,discrete gate or transistor logic, discrete hardware components, or anycombination thereof designed to perform the functions described herein.A general purpose processor may be a microprocessor, but in thealternative, the processor may be any conventional processor,controller, microcontroller, or state machine. A processor may also beimplemented as a combination of computing devices, e.g., a combinationof a DSP and a microprocessor, a plurality of microprocessors, one ormore microprocessors in conjunction with a DSP core, or any other suchconfiguration.

Any options available for a particular medical device system may beemployed with the present invention. For example, with aphacoemulsification system the available settings may include, but arenot limited to, irrigation, aspiration, vacuum level, flow rate, pumptype (flow based and/or vacuum based), pump speed, ultrasonic power(type and duration, e.g. burst, pulse, duty cycle, etc.), irrigationsource height adjustment, linear control of settings, proportionalcontrol of settings, panel control of settings, and type (or “shape”) ofresponse. As noted, control of the functionality or settings of thesystem may be performed by use of a foot pedal. Conversely, the systemmay notify a user of a system or environmental characteristic (such asan occlusion) by providing tactile feedback to a user via the footpedal.

The tactile notification in a foot pedal provides feedback to the usershould the pre-selected or automatic settings or criteria of the systemneed adjustment in light of an occlusion. Such adjustment may benecessary to ensure optimal use of the desired settings of the systemand the desired outcome of the surgery. In alternative embodiments, thefoot pedal can then also permit the user to change or modify thosesettings accordingly, for instance, by depressing a switch or thetreadle on the foot pedal.

The term “phacoemulsification” refers to a method of lens and cataractextraction from an eye. The procedure includes an ultrasonicallyvibrated needle which is inserted through a very small incision in thecornea in order to provide energy for emulsifying or breaking up of thelens and cataract which then can be aspirated and removed through theincision.

The term “vitrectomy surgery” refers to a method employed duringcataract surgery when the posterior capsular bag has been broken and inthe treatment of retinal detachments resulting from tears or holes inthe retina. In cataract surgery, the same incision used for thephacoemulsification handpiece is used for inserting the vitrector toremove the vitreous gel. Vitrectomy surgery typically involves removalof vitreous gel and may utilize three small incisions in the pars planaof the patient's eye. These incisions allow the surgeon to pass threeseparate instruments into the patient's eye to affect the ocularprocedure. The surgical instruments typically include a vitreous cuttingdevice, an illumination source, and an infusion/aspiration port(s), butthese devices may be combined into one single tool as well.

The term “screen,” “display,” or “display screen” as used herein shallmean a graphical user interface (GUI), a screen, a monitor, touchscreen, or any other device known in the art for displaying a visualpicture, words, or representation.

The previous description is provided to enable any person skilled in theart to make or use the disclosed embodiments. Various modifications tothese embodiments will be readily apparent to those skilled in the art,and the generic principles defined herein may be applied to otherembodiments without departing from the spirit or scope of the invention.Thus, the present disclosure is not intended to be limited to theembodiments shown herein but is to be accorded the widest scopeconsistent with the principles and novel features disclosed herein.

What is claimed is:
 1. An ocular surgical apparatus, comprising: ahandpiece configured to transport irrigation fluid into a patient's eyeand aspirate fluid from the patient's eye; an occlusion sensor capableof detecting whether an occlusion has occurred in the handpiece; and afoot pedal including an occlusion alarm, the occlusion alarm configuredto provide a tactile notification when an occlusion has occurred in thehandpiece.
 2. The apparatus of claim 1, further comprising a controlmodule operatively connected to the handpiece, occlusion sensor, andfoot pedal.
 3. The apparatus of claim 2, wherein the control modulereceive a signal from the occlusion sensor when an occlusion hasoccurred and communicates with the occlusion alarm to cause the tactilenotification.
 4. The apparatus of claim 1, wherein the foot pedalcomprises a housing, a base and a treadle.
 5. The apparatus of claim 4,wherein the occlusion alarm is coupled to a bottom surface of thetreadle.
 6. The apparatus of claim 1, wherein the occlusion alarmincludes a vibration mechanism.
 7. The apparatus of claim 6, wherein thevibration mechanism comprises a motor and an off-center weight.
 8. Theapparatus of claim 6, wherein the foot pedal comprises a housing, a baseand a treadle.
 9. The apparatus of claim 8, wherein the vibrationmechanism is coupled to a bottom surface of the treadle.
 10. Theapparatus of claim 8, wherein the vibration mechanism is adjacent a topheel surface of the housing, the top heel surface configured to beadjacent to a user's heel when using the foot pedal.
 11. The apparatusof claim 1, wherein the occlusion alarm includes a feedback mechanism.12. The apparatus of claim 11, wherein the feedback mechanism includes acompression member that applies compression force against a treadle ofthe foot pedal when an occlusion has occurred.
 13. The apparatus ofclaim 12, wherein the compression member including a biasing member. 14.A foot pedal for an ocular surgical apparatus, the foot pedalcomprising: a housing; a treadle rotatably coupled to the housing; analarm configured to receive a occlusion signal that indicates anocclusion has occurred in the surgical apparatus and provide tactilefeedback in response to the signal.
 15. The foot pedal of claim 14,wherein the alarm includes a motor connected to a control module of theapparatus via a communication path.
 16. The foot pedal of claim 15,wherein the communication path is wireless.
 17. The foot pedal of claim15, wherein the control module receives notice of an occlusion and sendthe occlusion signal to the alarm.
 18. The foot pedal of claim 14,wherein the foot pedal further includes a heel cup assembly.
 19. Thefoot pedal of claim 18, wherein the alarm is connected to the heel cupassembly.
 20. A process of indicating that an occlusion has occurred inan ocular surgical apparatus, the process comprising: detecting theocclusion; generating a notification signal of the occlusion; sendingthe notification signal to the foot pedal of the ocular surgicalapparatus; and causing a tactile indicator in the foot pedal when thefoot pedal receives the notification signal.
 21. The process of claim20, wherein the tactile indicator is a vibration.
 22. The process ofclaim 20, wherein the tactile indicator is a forced feedback.
 23. Theprocess of claim 20, wherein the step of generating a notificationsignal occurs within a control module of the ocular surgical apparatus.24. A method of detecting an ocular occlusion, the method comprising:providing at least one sensor communicatively coupled to a handpiececonfigured to transport irrigation fluid into a patient's eye andaspirate fluid from the patient's eye; generating at least one signalfrom the at least one sensor in accordance with the detecting of avariance from a predetermined pressure in the handpiece; and providingat least one notification in accordance with the at least one signal;wherein the at least one signal has a length indicative of the magnitudeof the variance from a predetermined pressure.
 25. The method of claim24, wherein the at least one notification includes a tactilenotification through a foot pedal communicatively coupled to thehandpiece.
 26. The method of claim 24, wherein the magnitude of thevariance from a predetermined pressure is a measured in time.
 27. Themethod of claim 24, wherein the magnitude of the variance from apredetermined pressure is a measurement of pressure.